Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support

Fudan University

Status: Withdrawn

Conditions: Mortality; Quality Improvement; Neonate; Intracranial Hemorrhage; Extracorporeal Life Support; Extracorporeal Membrane Oxygenation

Treatments: Behavioral: Collaborative quality improvement

Study type: Interventional

Funder types: Other

Identifiers

NCT05075486

CQI-RMSIH

Details and patient eligibility

About

This is a three-year pre- and post- interventional study to assess the effectiveness of collaborative quality improvement interventions on reducing mortality and severe intracranial hemorrhage (ICH) for neonates receiving extracorporeal life support (ECLS) in China.

Full description

This is a three-year pre- and post- interventional study from 2022 to 2024. The population of this study will be all neonates who receive ECLS support within 28 days of life in the participating hospitals of Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS). The intervention will be collaborative quality improvement interventions for each of the participating hospital. Detailed interventions include standardized ECLS data feedback and benchmark, establishment of potential better practice list, training on quality improvement, implementation of practice change using plan-do-study-action cycles, report and monitor of practice change and collaborative learning. The first year will be pre-intervention baseline period and serves as the control period. Collaborative quality improvement interventions will be introduced from the start of the second year and the second and third years will be the intervention period. The primary outcome, which is the incidence of mortality or severe ICH of the third year, will be compared to that of the baseline year.

Sex: All

Ages: 1 hour to 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≤28 days of life
• receive ECLS support

Exclusion criteria

• Infants with severe congenital anomalies
• Infants with pre-ECLS ICH

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intervention group

Experimental group

Description:

Group who recieve collaborative quality improvement during study period.

Treatment:

Behavioral: Collaborative quality improvement